Clinical Question: Are citalopram and fluoxetine effective therapies for vasomotor symptoms in menopausal women?
Setting: Outpatient (any)
Study Design: Randomized controlled trial (double-blinded)
Synopsis: In this well-designed clinical trial, 150 symptomatic, naturally menopausal women were assigned to one of three treatment groups: citalopram (10 mg), fluoxetine (10 mg), or placebo. The women were instructed to take one dose daily for month 1, two doses daily for months 2 through 6, and three doses daily after month 6, with permission to return to two doses per day if they experienced bothersome side effects. Only 30 women (approximately 60 percent) from each group completed the nine-month study, which was sufficient to detect a 20 percent difference in the principle outcome, the Kupperman index score, a frequently used menopause symptom index. No differences were noted in the Kupperman index scores during the study. No dose-response effect was observed as dosages increased.
No differences were found in other secondary measures, including number of hot flashes and Beck Depression Inventory score. Insomnia improved more in the citalopram group than in the placebo group. As in other studies of menopausal vasomotor symptoms, improvement over time was noted in all groups; approximately 60 percent of women in all three groups reported that vasomotor symptoms had decreased by one half or more at six months.
Bottom Line: Neither citalopram nor fluoxetine improved the vasomotor symptoms (i.e., hot flashes) of menopausal women more than placebo. As in other well-designed clinical trials of treatments for hot flashes, there was a marked placebo effect and improvement in all groups over time. (Level of Evidence: 1b)